The present invention relates to a pectin delivery system which can be efficiently prepared and provided to the consumer as an organoleptically-acceptable confectionary product. Products prepared in accordance with the present invention provide a means whereby relatively high percentages of insoluble solids can be delivered, i.e., drugs, nutritional supplements, sweeteners and the like in a pleasing, soft gel structure.
Prescribed daily dosage amounts of fiber are often very high, requiring the patient to administer the fiber or fiber composition several times per day. While their benefits are well known to the consuming public, the unpleasant fibrous mouthfeel and texture of products containing dietary fiber has resulted in reluctance of patients to comply with prescribed dosages.
Numerous fiber-containing products are available in the market in the form of breakfast cereals, laxative beverages, bran tablets and cereal bars. Snack meals consisting of granola-type bars and cookies have become increasingly popular as a substitute for traditional meals. Although these forms of fiber are generally pleasant tasting, they typically do not deliver high concentrations of fiber and suffer from high caloric content.
The awareness of the health benefits of fiber has been largely responsible for this popularity. Yet many fiber markets have experienced a consumer reluctance to eat sufficient amounts of fiber to provide the therapeutic benefits associated with fiber. This reluctance is usually due to the objectionable taste of the fiber, or the high calories associated with masking the objectionable taste. The dry, unpalatable texture and mouthfeel of fiber often requires the incorporation of fats and carbohydrates (masking agents) in amounts which effectively dilute the fiber dosage per unit of product. Commercially available confectionary products containing fiber are generally of the granola-type. Chocolate, fruits and nuts are often added to other confectionary ingredients to enhance the palatability of the final product.
In a related disclosure, U.S. application Ser. No. 875,429, filed June 17, 1986,now U.S. Pat. No. 4,698,272, a unique confectionary form for delivering fiber is provided which includes elements of nougat technology and boiled candy technology, as well as coating technology to achieve an acceptable composition having about 20 to 30% dietary fiber present. The solution provided in the above-referenced disclosure is excellent if the consumer finds the foamed matrix described therein desirable.
Furthermore, patient compliance with prescribed drug therapies is also a problem particularly when the drug has an unpleasant taste, after-taste or gritty mouthfeel. Drugs such as phenolphthalein, dextromethorphan, danthron, sennosides, cholestyramine and potassium chloride are known to taste unpleasant. The prior art has disclosed products to mask the taste of these drugs, but the products themselves often suffer from their own unpleasant tastes or texture. The trend, therefore, in patient use of the prior art products containing fiber or drugs has been to deviate from the prescribed dosage or frequency of dosage, thereby diminishing the effectiveness of the therapy.
Two patents which disclose palatable drug formulations use coacervation techniques to combine cholestyramine with modified celluloses. U.S. Pat. No. 3,947,272 shows oral palatable formulations containing aqueous media and cholestyramine. A method of treating hypercholesterolemia is claimed. Chewable products containing cellulosic/gum colloids are disclosed.
U.K. Patent No. 1,446,352 concerns palatable compositions useful for the treatment of hypercholesterolemia and biliary cirrhosis. The invention provides a liquid composition containing "coacervate of cholestyramine with a cellulose hydrocolloid" derivative. By the term "coacervate" is meant the coagulation of two hydrophilic substances of opposite charge. Representative hydrocolloids are methyl and ethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose. A water-insoluble dispersing agent, e.g., a substituted carboxymethyl starch, is optional. In making the composition, 1 part by weight of hydrocolloid is combined with 4 to 10 parts of cholestyramine by dry mixing and passing through a No. 80 U.S. standard mesh screen. The resulting powder is then mixed with a liquid to form a coacervate which can be orally administered.
In another related disclosure, U.S. application Ser. No. 698,511, filed Feb. 5, 1985, now U.S. Pat. No. 4,747,881, problems associated with organoleptic acceptability of fiber and drugs are remedied by formation of an aggregate having a particle size of about 4 to about 70 standard mesh. The aggregate includes a substantially anhydrous pre-swelled hydrocolloid and a substrate. Unpleasant taste and undesirable mouthfeel of fiber and/or drug is effectively masked and substantial hydration is delayed until the composition passes through the oral cavity.
While gel systems might provide an acceptable alternative delivery system, several features of gel manufacture and product characteristics discourage the use of an otherwise appealing delivery system. For example, normal gel production requires several steps generally including cooking or concentrating, depositing or moulding, drying or storing, removal from starch molds, cleaning of both the product and the mold, and sugar sanding or crystallizing or glazing. Additionally, heat sensitive active ingredients can undergo degradation since uniform distribution throughout the gel product usually requires addition of the active before cooking. Thus from a production standpoint, a gel dosage delivery system is considered much too labor-, equipment-, time-, and energy-intensive. Furthermore, it is well known that many gels resist complete dissolution in an aqueous environment and little, if any, control can be provided to the release of a unit dosage of active ingredient from the gel.
It has now been discovered, however, that the drawbacks generally occasioned by inclusion of fiber and drugs are significantly reduced and, in some cases, completely obviated by providing a gel delivery system which utilizes the natural aqueous environment of the oral cavity to mask and accelerate passage of the dissolved active ingredients during ingestion. Furthermore, the problems associated with the laborious process for preparing a suitable gel product have been overcome.